MAUDE Adverse Event Report: B. BRAUN MEDICAL INTROCAN SAFETY IV CATHETER; INTRAVENOUS CATHETER, SHORT TERM

Catalog Number 4252500-02

Device Problems Material Frayed (1262); Out-Of-Box Failure (2311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2015

Event Type  malfunction  

Event Description

The nurse was caring for an infant who needed an iv start.She opened the package to use a 24 gauge catheter with safety needle and noted the end to be frayed prior to using.No package was saved, catheter saved and is available to the manufacturer upon their request.

• Brand Name: INTROCAN SAFETY IV CATHETER
• Type of Device: INTRAVENOUS CATHETER, SHORT TERM
• Manufacturer (Section D): B. BRAUN MEDICAL; 901 marcon boulevard; allentown, PA 18109
• MDR Report Key: 4823649
• MDR Text Key: 5901462
• Report Number: 4823649
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 4252500-02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2015
• Patient Sequence Number: 1